CLENZIDERM M.D. SYSTEM ACNE THERAPEUTIC SYSTEM- salicylic acid and benzoyl peroxide kit

United States - English - NLM (National Library of Medicine)

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Active ingredient:
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)
Available from:
OBAGI COSMECEUTICAL LLC
Prescription type:
OTC DRUG
Therapeutic indications:
Acne treatment - for the treatment of acne - dries up acne pimples - helps prevent new acne pimples Acne treatment - for the treatment of acne - dries up acne pimples - helps prevent new acne pimples Acne treatment - for the treatment of acne - dries up acne pimples - helps prevent new acne pimples
Authorization status:
OTC monograph final
Authorization number:
62032-610-04, 62032-611-01, 62032-612-04, 62032-613-01

CLENZIDERM M.D. SYSTEM ACNE THERAPEUTIC SYSTEM- salicylic acid and benzoyl

peroxide

OBAGI COSMECEUTICAL LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

CLENZIDERM M.D.™ SYSTEM

ACNE THERAPEUTIC SYSTEM

Daily Care Foaming Cleanser

4 fl. oz. (118 mL) AM+PM

Drug Facts

Active ingredient

Salicylic acid 2%

Purpos e

Acne treatment

Us es

for the treatment of acne

dries up acne pimples

helps prevent new acne pimples

Warnings

For external use only

When using this product

skin irritation and dryness is more likely to occur if you use another topical acne medication at the

same time. If irritation occurs, only use one topical acne medication at a time.

Stop use and ask a doctor if

irritation becomes severe.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right

away.

Directions

Cleanse the entire affected area with a thin layer and rinse thoroughly one to three times daily.

Because excessive drying of the skin may occur, start with one application daily, then gradually

increase to two or three times daily if needed or as directed by a doctor.

If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

Other information

Store away from heat and direct sunlight.

Store at controlled room temperature: 15°C–25°C (59°F– 77°F).

Inactive ingredients

butyl avocadate, cetyl hydroxyethylcellulose, chamomilla recutita (matricaria) flower extract,

cocamidopropyl betaine, disodium EDTA, ethoxydiglycol, ext. violet 2, fragrance, glycerin, menthol,

menthyl lactate, sodium laureth sulfate, sodium lauryl sulfate, water (aqua)

Questions or comments?

1.800.636.7546

Monday–Friday 9a.m.–4p.m. Pacific Time

Pore Therapy

5 fl. oz. (148 mL) AM+PM

Drug Facts

Active ingredient

Salicylic acid 2%

Purpos e

Acne treatment

Us es

for the treatment of acne

dries up acne pimples

helps prevent new acne pimples

Warnings

For external use only

When using this product

skin irritation and dryness is more likely to occur if you use another topical acne medication at the

same time. If irritation occurs, only use one topical acne medication at a time.

Stop use and ask a doctor if

irritation becomes severe.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right

away.

Directions

Cleanse the skin thoroughly before applying this product.

Shake product well before use.

Place a cotton ball or pad over the pump well and pump 2 to 3 times to saturate, then cover the entire

affected area with a thin layer one to three times daily.

Allow the product to air-dry completely; do not rinse off.

Because excessive drying of the skin may occur, start with one application daily, then gradually

increase to two or three times daily if needed or as directed by a doctor.

If bothersome dryness or peeling occurs, reduce application to once a day or every other day .

Other information

Store away from heat and direct sunlight.

Store at controlled room temperature: 15°C–25°C (59°F– 77°F).

Inactive ingredients

benzyl alcohol, chamomilla recutita (matricaria) flower extract, ethoxydiglycol, ext. violet 2, fragrance,

glycerin, menthol, menthoxypropanediol, menthyl lactate, SD alcohol 40-B, water (aqua)

Questions or comments?

1.800.636.7546

Monday–Friday 9a.m.–4p.m. Pacific Time

Therapeutic Lotion

1.6 fl. oz. (47 mL) AM+PM

Drug Facts

Active ingredient

Benzoyl peroxide 5%

Purpos e

Acne treatment

Us es

for the treatment of acne

dries up acne pimples

helps prevent new acne pimples

Warnings

For external use only

When using this product

skin irritation and dryness is more likely to occur if you use another topical acne medication at the

same time. If irritation occurs, only use one topical acne medication at a time

avoid unnecessary sun exposure and use a sunscreen

avoid contact with the eyes, lips, and mouth

avoid contact with hair and dyed fabrics, which may be bleached by this product

skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling.

Irritation may be reduced by using the product less frequently or in a lower concentration.

Do not use if you

have very sensitive skin.

are sensitive to benzoyl peroxide.

Stop use and ask a doctor if

irritation becomes severe.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right

away.

Directions

Cleanse the skin thoroughly before applying this product.

Cover the entire affected area with a thin layer one to three times daily.

Because excessive drying of the skin may occur, start with one application daily, then gradually

increase to two or three times daily if needed or as directed by a doctor.

If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

If going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop

use of both products and ask a doctor.

Other information

Store away from heat and direct sunlight.

Store at controlled room temperature: 15°C–25°C (59°F– 77°F).

Inactive ingredients

benzyl benzoate, BHT, dicaprylyl ether, dimethyl isosorbide, disodium EDTA, hydroxyethyl

acrylate/sodium acryloyldimethyl taurate copolymer, phenoxyethanol, polysorbate 60, propylene

glycol, squalane, water (aqua)

Questions or comments?

1.800.636.7546

Monday–Friday 9a.m.–4p.m. Pacific Time

Distributed by Obagi Cosmeceuticals LLC,

Long Beach, CA 90806

PRINCIPAL DISPLAY PANEL - Kit Carton

OBAGI

MEDICAL

CLENZIderm M.D.™ SYSTEM

Acne Therapeutic System

This CLENZIderm M.D. SYSTEM includes:

Daily Care Foaming Cleanser 4 fl. oz. (118 mL)

Pore Therapy 5 fl. oz. (148 mL)

Therapeutic Lotion 1.6 fl. oz. (47 mL)

CLENZIDERM M.D. SYSTEM ACNE THERAPEUTIC SYSTEM

salicylic acid and benzoyl peroxide kit

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 20 32-6 13

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 20 32-6 13-0 1

1 in 1 CARTON; Type 0 : No t a Co mbinatio n Pro duct

0 1/0 1/20 12

Quantity of Parts

Part #

Package Quantity

Total Product Quantity

Pa rt 1

1 BOTTLE, PLASTIC

118 mL

Pa rt 2

1 BOTTLE, PLASTIC

148 mL

Pa rt 3

1 BOTTLE, PLASTIC

47 mL

Part 1 of 3

CLENZIDERM DAILY CARE FOAMING CLEANSER ACNE TREATMENT

salicylic acid liquid

Product Information

Ite m Code (Source )

NDC:6 20 32-6 10

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)

SALICYLIC ACID

20 mg in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

SO DIUM LAURETH-3 SULFATE (UNII: BPV39 0 UAP0 )

SO DIUM LAURYL SULFATE (UNII: 36 8 GB5141J)

CO CAMIDO PRO PYL BETAINE (UNII: 5OCF3O11KX)

CETYL HYDRO XYETHYLCELLULO SE ( 3 50 0 0 0 MW) (UNII: T7SWE4S2TT)

EDETATE DISO DIUM (UNII: 7FLD9 1C8 6 K)

MENTHO L, UNSPECIFIED FO RM (UNII: L7T10 EIP3A)

MENTHYL LACTATE, ( -) - (UNII: 2BF9 E6 5L7I)

EXT. D&C VIO LET NO . 2 (UNII: G5UX3K0 728 )

WATER (UNII: 0 59 QF0 KO0 R)

DIETHYLENE GLYCO L MO NO ETHYL ETHER (UNII: A1A1I8 X0 2B)

CHAMO MILE (UNII: FGL36 8 5T2X)

Glycerin (UNII: PDC6 A3C0 OX)

Product Characteristics

Color

PURPLE

S core

S hap e

S iz e

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:6 20 32-6 10 -

118 mL in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC MONOGRAPH FINAL

pa rt333D

0 2/0 1/20 0 7

Part 2 of 3

CLENZIDERM PORE THERAPY ACNE TREATMENT

salicylic acid liquid

Product Information

Ite m Code (Source )

NDC:6 20 32-6 12

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)

SALICYLIC ACID

20 mg in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

ALCO HO L (UNII: 3K9 9 58 V9 0 M)

DIETHYLENE GLYCO L MO NO ETHYL ETHER (UNII: A1A1I8 X0 2B)

BENZYL ALCO HO L (UNII: LKG8 49 4WBH)

3 -( ( L-MENTHYL) O XY) PRO PANE-1,2 -DIO L (UNII: KD6 TZ2QICH)

GLYCERIN (UNII: PDC6 A3C0 OX)

MENTHO L, UNSPECIFIED FO RM (UNII: L7T10 EIP3A)

MENTHYL LACTATE, ( -) - (UNII: 2BF9 E6 5L7I)

EXT. D&C VIO LET NO . 2 (UNII: G5UX3K0 728 )

WATER (UNII: 0 59 QF0 KO0 R)

CHAMO MILE (UNII: FGL36 8 5T2X)

Product Characteristics

Color

PURPLE

S core

S hap e

S iz e

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:6 20 32-6 12-

148 mL in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC MONOGRAPH FINAL

pa rt333D

0 2/0 1/20 0 7

Part 3 of 3

CLENZIDERM THERAPEUTIC

benzoyl peroxide lotion

Product Information

Ite m Code (Source )

NDC:6 20 32-6 11

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

BENZO YL PERO XIDE (UNII: W9 WZN9 A0 GM) (BENZOYL PEROXIDE - UNII:W9 WZN9 A0 GM)

BENZOYL PEROXIDE 50 mg in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

BENZYL BENZO ATE (UNII: N8 6 3NB338 G)

DICAPRYLYL ETHER (UNII: 77JZM5516 Z)

HYDRO XYETHYL ACRYLATE/SO DIUM ACRYLO YLDIMETHYL TAURATE CO PO LYMER ( 10 0 0 0 0 MPA.S AT

1.5%) (UNII: 8 6 FQE9 6 TZ4)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

SQ UALANE (UNII: GW8 9 575KF9 )

PO LYSO RBATE 6 0 (UNII: CAL22UVI4M)

DIMETHYL ISO SO RBIDE (UNII: SA6 A6 V432S)

PHENO XYETHANO L (UNII: HIE49 2ZZ3T)

EDETATE DISO DIUM (UNII: 7FLD9 1C8 6 K)

BUTYLATED HYDRO XYTO LUENE (UNII: 1P9 D0 Z171K)

WATER (UNII: 0 59 QF0 KO0 R)

Product Characteristics

Color

WHITE

S core

S hap e

S iz e

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:6 20 32-6 11-

47 mL in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC MONOGRAPH FINAL

pa rt333D

0 7/0 1/20 0 7

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC MONOGRAPH FINAL

pa rt333D

0 1/0 1/20 12

Labeler -

OBAGI COSMECEUT ICAL LLC (790553353)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

OBAGI COSMECEUTICAL LLC

G.S.COSMECEUTICAL USA, INC.

0 170 14734

MANUFACTURE(6 20 32-6 13)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

PURETEK CORPORATION

78 59 6 10 46

MANUFACTURE(6 20 32-6 13) , LABEL(6 20 32-6 13) , PACK(6 20 32-6 13)

Revised: 3/2019

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